Search Results
Found 1 results
510(k) Data Aggregation
K Number
K210006Device Name
MI DeTACH
Manufacturer
Biorep Technologies, Inc
Date Cleared
2021-03-04
(59 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Biorep Technologies, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MI DeTACH® is indicated for use for temporary or partial occlusion of blood vessels during cardiovascular surgical procedures.
Device Description
The MI DeTACH® is comprised of a Detachable Aortic Clamp Head and a Delivery System. The MI DeTACH® Detachable Aortic Cross Clamp Head is available in three sizes: Small, Medium, and Large (55mm, and 85mm enqagement pads respectively) which are packaged and distributed separately. The Delivery System is comprised of a Delivery Device and Quick Release Device. The Delivery Device is used to deliver, clamp, deploy, unclamp, and retrieve the Clamp Head from the target occlusion site.
The MI DeTACH® Detachable Aortic Cross Clamp Head works by applying compression forces to the vessel by the padded device jaws. The top jaw is a pivot jaw allowing for parallel closure of the vessel during clamping. The amount of compression applied to the vessel for occlusion or partial occlusion is determined or adjusted by the means of the Delivery Device lever actuated jaw closure mechanism. The Clamp Head device contains ratchets that provide clamping tactile feedback to the user. A clutch mechanism prevents the user from applying excessive forces to the vessel by disengaging the lever from the device when specific force is obtained. Upon successfully clamping, the device locks and the handle is then detached leaving the clamp in the body throughout the duration of the procedure. The Delivery Device is then used to unclamp and remove the Clamp Head from the body upon procedure completion. In the event the Delivery Device becomes compromised during the course of a procedure, the Quick Release Device can be used to unclamp and remove the Clamp Head from the body.
Ask a Question
Page 1 of 1